Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Directive 2011/65/EU of the European Parliament and of the Council as regards the re-attribution of scientific and technical tasks to the European Chemicals Agency
Date: 2023-12-07
Institutions: Directorate-General for Environment, European Commission
Subjects: European Chemicals Agency, chemical product, chemicals legislation, dangerous substance, electrical equipment, electronic equipment, operation of the Institutions, scientific report

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   EUROPEAN COMMISSION  Brussels, 7.12.2023  COM(2023) 781 final 2023/0454 (COD)  Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Directive 2011/65/EU of the European Parliament and of the Council as regards the re-attribution of scientific and technical tasks to the European Chemicals Agency  (Text with EEA relevance) {SWD(2023) 850 final}  
 
EXPLANATORY MEMORANDUM 

1. 

• 

CONTEXT OF THE PROPOSAL 

Reasons for and objectives of the proposal 

The European Union has developed a comprehensive regulatory framework for chemicals to 
ensure  a  high  level  of  protection  of  human  health  and  the  environment  from  the  harmful 
effects  of  chemicals,  support  the  efficient  functioning  of  the  internal  market  for  chemicals, 
and promote the competitiveness and innovation of EU industry. The framework consists of 
over  40  pieces  of  legislation  addressing:  (i)  the  production  and  placing  on  the  market  of 
chemicals  and  products  containing  chemicals;  (ii)  emissions  of  chemicals  and  safety  of 
workers; (iii) consumer products; (iv) food and feed stuff; (v) and the environment. 
The fitness check of the most relevant EU chemicals legislation1 concluded that, overall, this 
legislation  delivers  the  intended  results  and  is  fit  for  purpose.  However,  there  are 
shortcomings  in  the  consistency  of  safety  assessments,  the  efficiency  of  the  underlying 
technical and scientific work, and the consistency of transparency rules.  

The implementation of the individual legislative instruments is supported by a large volume 
of technical and scientific work. Depending on the legislation in question, the work is initiated 
by different bodies at different points in time, using different data and carried out by certain 
EU agencies (the European Chemicals Agency (ECHA), the European Food Safety Authority, 
the  European  Environment  Agency  and  the  European  Medicines  Agency),  scientific 
committees, expert groups, Commission departments and contractors. This sometimes leads to 
inconsistent outcomes of assessments for the same chemicals across different legislation. This 
is  an  inefficient  use  of  resources  and  carries  unnecessary  costs  –  from  operating  multiple 
committees  conducting  similar  assessments,  to  assessing  the  same  chemical  by  several 
committees/bodies  and  duplicating  supporting  technical  and  scientific  work  with  potentially 
diverging outcomes of the hazard or risk assessment. In addition, the assessments that are not 
carried  out  by  the  EU  agencies  are  sometimes  criticised  by  stakeholders  as  not  being 
transparent and inclusive enough and not having sufficient scientific quality and robustness. 
Building  on  the  findings  of  the  fitness  check,  the  European  Green  Deal2  put  forward  the 
commitment  ‘to  review  how  to  use  better  the  EU’s  agencies  and  scientific  bodies  to  move 
towards  a  process  of  ‘one  substance,  one  assessment’  and  to  provide  greater  transparency 
when  prioritising  action  to  deal  with  chemicals.  The  chemicals  strategy  for  sustainability3 
(hereby  ‘Strategy’)  developed  the  concept  of  ‘one  substance,  one  assessment’  further  and 
described it as an approach to improve the overall efficiency, consistency and transparency of 
the delivery of chemical safety assessments across legislation. 

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3 

Commission  Staff  Working  Document  Fitness  Check  of  the  most  relevant  chemicals  legislation 
(excluding  REACH),  as  well  as  related  aspects  of  legislation  applied  to  downstream  industries 
accompanying the document: Report from the Commission to the European Parliament, the Council, the 
European Economic and Social Committee and the Committee of the Regions: Findings of the Fitness 
Check  of  the most  relevant  chemicals  legislation  (excluding  REACH)  and  identified  challenges,  gaps 
and weaknesses (SWD(2019) 199). 

Communication from the Commission to the European Parliament, the European Council, the Council, 
the European Economic and Social Committee and the Committee of the Regions: The European Green 
Deal (COM/2019/640 final). 

Communication  from  the  Commission  to  the  European  Parliament,  the  Council,  the  European 
Economic  and  Social  Committee  and  the  Committee  of  the  Regions:  Chemicals  Strategy  for 
Sustainability Towards a Toxic-Free Environment (COM(2020) 667 final). 

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Two key measures set out in the strategy to improve the overall efficiency, consistency and 
transparency aim to: 

• 

‘rationalise  the  use  of  expertise  and  resources  by  proposing  the  reattribution  of 
technical and scientific work on chemicals performed under the relevant pieces of 
legislation to European agencies’; 

•  ensure  ‘a  clear  allocation  of  responsibilities  and  good  cooperation  among  the 
European  agencies’.  The  Council4  welcomed  the  ‘one  substance,  one  assessment’ 
initiative  and  the  European  Parliament5  welcomed  the  ‘one  substance,  one  hazard 
assessment’ approach. 

Reallocating  existing  tasks  and  allocating  new  tasks  to  EU  agencies  require  targeted 
amendments of the existing pieces of chemicals legislation. The preferred way of doing it is 
by introducing changes in the allocation of tasks when the individual pieces of legislation are 
being revised. However, a full revision of individual pieces of legislation is not always timely 
nor appropriate, thus amendments are necessary to adapt such pieces of legislation outside of 
a full revision.   

This  is  the  case  for  the  Regulations:  Regulation  (EU)  2019/1021  on  persistent  organic 
pollutants  (‘POPs  Regulation’)6  and  Regulation  (EU)  2017/745  on  medical  devices7.  The 
amendments  of  the  regulations  are  proposed  by  a  proposal  for  a  Regulation  (‘Omnibus 
Regulation’)8. The ECHA should be assigned to carry out scientific and technical tasks related 
to  chemicals  described in  both  regulations. The respective proposal  also  amends Regulation 
(EC)  No 401/2009  establishing  the  European  Environmental  Agency9  and  Regulation  (EC) 
No 178/2002  laying  down  the  general  principles  and  requirements  of  food  law,  establishing 
the European Food Safety Authority and laying down procedures in matters of food safety10 
to  ensure  good  cooperation  among  EU  agencies  on  all  aspects  involving  the  efficiency, 
consistency and transparency of chemical assessments.  

This proposal focuses on amending the Directive 2011/65/EU on the restriction of the use of 
certain hazardous substances in electrical and electronic equipment (‘RoHS Directive’)11. This 
proposal  follows  the  ‘one  substance,  one  assessment’  approach  and  aims  at  a  limited 
amendment of Directive 2011/65/EU in order to allocate the existing scientific and technical 

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Council Conclusions on Sustainable Chemicals Strategy of the Union, 2021. 
European  Parliament  resolution  of  10 July  2020  on  the  Chemicals  Strategy  for  Sustainability 
(2020/2531(RSP)) (OJ C 371, 15.9.2021, p.75). 
Regulation  (EU)  2019/1021  of  the  European  Parliament  and  of  the  Council  of  20  June  2019  on 
persistent organic pollutants (OJ L 169 25.6.2019, p. 45). 
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical 
devices,  amending  Directive  2001/83/EC,  Regulation  (EC)  No  178/2002  and  Regulation  (EC)  No 
1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117 5.5.2017, p. 1). 
Proposal for a Regulation of the European Parliament and of the Council amending Regulations (EC) 
No 178/2002, (EC) No 401/2009, (EU) 2017/745 and (EU) 2019/1021 of the European Parliament and 
of the Council as regards the re-attribution of scientific and technical tasks and improving cooperation 
among Union agencies in the area of chemicals 
Regulation (EC) No 401/2009 of the European Parliament and of the Council of 23 April 2009 on the 
European Environment Agency and the European Environment Information and Observation Network 
(OJ L 126 21.5.2009, p. 13). 
Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying 
down  the  general  principles  and  requirements  of  food  law,  establishing  the  European  Food  Safety 
Authority and laying down procedures in matters of food safety (OJ L 031 1.2.2002, p. 1). 
Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction 
of the use of certain hazardous substances in electrical and electronic equipment (OJ L 174 1.7.2011, p. 
88). 

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tasks  to  the  European  Chemical  Agency.  This  proposal  is  therefore  closely  linked  to  the 
Omnibus Regulation  to ensure consistency, to  comply with  the concept  ‘one substance, one 
assessment’ and to complete the re-attribution of tasks for Directive 2011/65/EU.  

The objectives of the proposal are to ensure that:  

•  allocation  of  responsibilities  for  performing  the  assessments  and  the  underlying 
technical  and scientific  work on chemicals  is  clear, exploits  and maximises synergies 
and makes the best use of available expertise and resources; 

•  deliverables  are  of  high  scientific  quality  and  the  procedures  are  transparent  and 

inclusive. 

• 

Consistency with existing policy provisions in the policy area 

As described above, this proposal is linked to the Omnibus Regulation but also to a proposal 
for  a  Regulation  of  the  European  Parliament  and  of  the  Council  on  chemicals  data.  That 
proposal  will,  among  others,  aim  to  strengthen  sharing  and  reusing  chemical  data  and 
information  among  EU  agencies  and  Member  State  competent  authorities.  This  will  further 
contribute to improving the consistency, efficiency and transparency of chemical assessments 
across legislation.  

This  proposal  relates  to  the  general  review  of  Directive  2011/65/EU  under  Article 24(2)  of 
that Directive. The review, launched with the evaluation process in 2018 and concluded with 
the review report requested by Article 24(2), the staff working document on the evaluation12 
and  this  proposal,  identified  the  need  to  strengthen  consistency  and  maximise  synergies 
between Directive 2011/65/EU and chemicals  legislation, particularly  in the two assessment 
procedures under Directive 2011/65/EU which require scientific and technical expertise in the 
field of chemicals.  

Directive 2011/65/EU currently restricts the use of 10 substances and substance groups listed 
in  Annex  II  to  that  Directive.  Article  6(1)  lays  down  a  procedure  for  a  periodic  review  of 
Annex  II  on  the  Commission’s  initiative  or  following  the  submission  of  a  proposal  by  a 
Member State. The procedure is not described in detail in Article 6(1), it only includes how to 
initiate  the  review  and  the  obligation  to  consult  interested  parties.  In  order  to  increase  the 
transparency  of  the  restriction  process,  there  is  a  need  to  set  out  key  steps  in  the  process 
explaining how to review and amend the list of restricted substances. 

The second paragraph of Article 6(1) contains criteria for the review and amendment of the 
list  of  restricted  substances  in  Annex  II.  The  first  criterion  is  that  amendments  should  be 
‘coherent’  with  other  legislation  related  to  chemicals,  in  particular  Regulation  (EC)  No 
1907/2006  (‘REACH  Regulation’)13  and,  inter  alia,  Annexes  XIV  and  XVII  to  that 
Regulation.  In  order  to  identify  substances  for  a  potential  restriction  and  to  assess  whether 
they meet the criteria under Article 6(1), the European Commission contracts external experts 
to gather evidence, to provide expertise and, finally, to prepare a dossier about the substance. 

Article 4(6)  of  the  Directive  allows  time-limited  and  application-specific  exemptions  for 
technical applications listed in Annexes III and IV, to which the substance restrictions do not 

12 
13 

Staff working document on the evaluation of the RoHS Directive (SWD (2023) 760) 
Regulation  (EC)  No 1907/2006  of  the  European  Parliament  and  of  the  Council  of  18 December  2006 
concerning  the  Registration,  Evaluation,  Authorisation  and  Restriction  of  Chemicals  (REACH), 
establishing  a  European  Chemicals  Agency,  amending  Directive  1999/45/EC  and  repealing  Council 
Regulation  (EEC)  No 793/93  and  Commission  Regulation  (EC)  No 1488/94  as  well  as  Council 
Directive  76/769/EEC  and  Commission  Directives  91/155/EEC,  93/67/EEC,  93/105/EC  and 
2000/21/EC (OJ L 396, 30.12.2006 , p.1). 

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apply.  The  industry  can  submit  applications  for  time-limited  exemptions.  Annex  III 
exemptions can apply to all categories of electrical and electronic equipment, while Annex IV 
lists  applications  specific  to  medical  devices  and  monitoring  and  control  instruments. 
Article 5(1) defines the process and criteria whereby the European Commission adds, amends 
or  deletes  materials  and  components  of  electrical  and  electronic  equipment  for  specific 
applications  in  Annexes  III  and  IV.  The  first  criterion  for  an  inclusion  of  materials  and 
components  of  electrical and  electronic equipment  in  the lists in  Annexes  III and  IV is  that 
their  inclusion  does  not  weaken  the  environmental  and  health  protection  afforded  by  the 
REACH  Regulation.  When  assessing  whether  to  add,  amend  or  delete  exemptions,  the 
Commission  requests  external  experts  to  evaluate  exemption  requests  from  industry  and  to 
assess if any of the criteria in Article 5(1)(a) is met. 

The  condition  to  be  consistent  with  decisions  and  practice  under  the  REACH  Regulation 
shows  that  both  procedures  require  close  coordination  with  the  REACH  Regulation.  In 
addition, there can be single cases in which interfaces with other legislation are relevant, e.g. 
the  POPs  Regulation,  which  may  restrict  substances  covered  by  the  RoHS  Directive  in 
articles.  By  allocating  the  existing  scientific  and  technical  assessment  procedures  to  the 
European Chemical  Agency, the consistency between existing  policy provisions is  expected 
to increase.  

The  REACH  Regulation  has  two  assessment  processes  resembling  the  two  processes  under 
the  RoHS  Directive:  The  authorisation  process  under  title  VII  and  the  restriction  process 
under title VIII of the REACH Regulation. While there are important differences due to the 
different  nature  and  motivation  of  the  legislation,  these  processes  can  be  compared  to  and 
correspond  in  the  broadest  sense  to,  respectively,  the  substance  restriction  process  and  the 
exemption  process  under the RoHS  Directive. By streamlining the substance  restriction  and 
exemption  process  under  the  RoHS  Directive  with  the  restriction  and  authorisation  process 
under the REACH Regulation, authorities and stakeholders can benefit of aligned procedures 
based on methodologies established under REACH and managed by the ECHA. To improve 
the  scientific  robustness  of  assessments,  the  scientific  committees  in  the  ECHA  should  be 
involved  for  the  exemption  and  substance  restriction  process,  similar  to  the  REACH 
processes.    

• 

Consistency with other Union policies 

Allocating  and  reallocating  scientific  and  technical  tasks  in  the  assessment  of  chemicals  to 
ECHA is consistent with the objectives of the Better Regulation agenda. EU agencies benefit 
from robust scientific expertise and transparent and inclusive processes, which help ensure the 
support to policymaking. Consolidating the EU agencies’ work and thus lowering the number 
of  bodies  involved  contributes  to  simplifying  and  standardising  procedures  and  reducing 
administrative burden. 

2. 

• 

LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY 

Legal basis 

The  legal  basis  for  this  proposal  is  Article  114  of  the  Treaty  on  the  Functioning  of  the 
European Union. The proposal is a directive that amends an existing directive the legal basis 
of which is Article 114. Therefore, it is appropriate to base this Directive on the same Article. 

• 

Subsidiarity (for non-exclusive competence)  

The initiative will amend Directive 2011/65/EU in a targeted manner.  

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The  amendment  is  strictly  limited  to  the  allocation  of  tasks  for  conducting  scientific  and 
technical work at EU level, which is necessary for the operation of those instruments. Given 
that  the  Member  States  are  not  in  a  position  to  ensure  the  re-attribution  of  tasks  to  the  EU 
Agencies, which are EU bodies regulated at the EU level, the objective can only be achieved 
at EU level, thus respecting the subsidiarity principle. 

The  two  procedures  described  under  Article  5  and  Article  6  are  applicable  at  the  EU  level. 
National provisions should not deviate from these Articles set in Directive 2011/65/EU. 

Under the exemption  procedure of Article 5, economic operators can initiate the process  by 
submitting  an  application.  In  the  context  of  the  procedure  for  the  review  of  substances  to 
amend  the  list  of  restricted  substances  pursuant  to  Article  6,  Member  States  or  the 
Commission  can  initiate  the  process.  All  parties  involved  in  the  process  can  consult  the 
provisions of Directive 2011/65/EU for the sake of legal certainty.  

• 

Proportionality 

The initiative does not go beyond what is necessary to achieve the desired objectives. 

The review of Directive 2011/65/EU concluded that a full revision of that Directive was not 
appropriate nor timely14 but the procedures for substance restrictions laid down in Articles 5 
and  6  of  the  Directive  leave  room  for  improvement  which  can  be  addressed  by  a  targeted 
amendment  of  the  procedural  steps  under  the  concept  of  ‘one  substance,  one  assessment’. 
Therefore, only Articles 5 and 6 are subject to revision. The proposed amendments are kept to 
a minimum and do not affect the substantive requirements that form the basis for the adoption 
of substance restrictions or corresponding exemptions. 

• 

Choice of the instrument 

The desired changes require targeted amendments of specific provisions related to roles and 
tasks of Agencies in scientific assessments under Directive 2011/65/EU.  

In  accordance  with  the  principle  of  the  "parallélisme  des  formes",  a  Directive  is  to  be 
amended  by  a  Directive,  for  reasons  of  legal  certainty,  clarity  and  transparency.  It  was 
therefore not appropriate to include this proposal in the Omnibus Regulation. Instead, while 
being  closely  linked to  the Omnibus Regulation,  a limited number of selected  provisions of 
Directive 2011/65/EU is amended by this separate Directive. 

3. 

• 

RESULTS 
CONSULTATIONS AND IMPACT ASSESSMENTS 

EX-POST 

EVALUATIONS, 

OF 

STAKEHOLDER 

Ex-post evaluations/fitness checks of existing legislation 

Article 24(2) of Directive 2011/65/EU requires the Commission to carry out a general review 
of the Directive. The general review of Directive 2011/65/EU concluded that the Directive is 
a  well-functioning  instrument.  The  Directive  has  helped  to  reduce  hazardous  substances  in 
electrical  and  electronic  equipment  in  the  EU  and  to  protect  human  health  and  the 
environment at different stages of the value chain. 

Nevertheless,  the  general  review  identified  procedural  shortcomings  in  the  processes  for 
deciding  on  exemptions  and  updating  substance  restrictions  under  Directive  2011/65/EU 
concluding  that  these  processes  are  to  some  extent  lacking  transparency  and  efficiency  and 

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Report  from  the  Commission  to  the  European  Parliament,  the  Council,  the  European  Economic  and 
Social Committee and the Committee of the Regions on the review of the Directive on the restriction of 
the use of certain hazardous substances in electrical and electronic equipment 

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can  be  improved  in  terms  of  scientific  robustness.  Some  methodological  and  procedural 
differences were also identified between preparatory work for the substance restriction under 
the  RoHS  Directive,  on  the  one  hand,  and  for  the  substance  restrictions  and  authorisations 
under  the  REACH  Regulation  on  the  other.  Lacking  coordination,  possible  repetitive  or 
overlapping assessments, and increasing risk that provisions are misunderstood were the main 
identified  shortcomings.  These  shortcomings  can  lead  to  inconsistent  chemical  assessments, 
slow  procedures,  inefficient  use  of  resources,  unnecessary  burdens,  a  (perceived)  lack  of 
transparency,  and  an  impact  on  the  quality  of  scientific  advice.  The  review  has  shown  that 
allocating  the  two  processes  under  the  remit  of  the  ECHA  can  address  those  problems  and 
take advantage of opportunities. It would simplify the current set-up, improve the quality of 
assessments, and ensure predictability for stakeholders and the public. 

In  addition,  the  fitness  check  of  the  most  relevant  chemicals  legislation  (assessing  over  40 
pieces  of  legislation,  except  the  REACH  Regulation)  was  carried  out  in  2019.  The  fitness 
check showed that there are significant opportunities for streamlining EU agencies’ technical 
and scientific work. This would improve the efficiency of chemicals legislation (e.g. avoiding 
duplication  of  efforts  and  making  the  best  use  of  available  expertise  in  EU  agencies)  and 
make  it  more  consistent  (e.g.  reducing  the  risk  of  different  outcomes  of  hazard  or  risk 
assessments at EU level).  

• 

Stakeholder consultations 

During the evaluation of that Directive, the Commission published an evaluation roadmap for 
the RoHS Directive in 2018, which was open for public feedback from 14 September 2018 to 
12  October  2018  and  received  20  responses.  Stakeholders  were  invited  to  participate  in  the 
open public consultation (OPC) organised by the Commission for 12 weeks until 6 December 
2019.  In  total,  163  responses  were  collected.  In  parallel  to  the  OPC,  an  in-depth  survey 
(questionnaire)  was  shared  with  Member  State  authorities  involved  in  implementing  the 
RoHS  Directive.  A  total  of  20  responses  were  received.  Between  October  2019  and  March 
2020,  three  focus  group  meetings  were  organised  covering  the  following  topics:  (i)  for 
Member  States  authorities  regarding  assessment  of  implementation  and  enforcement  of  the 
Directive,  (ii)  for  NGOs  regarding  effectiveness  and  efficiency  –  environmental  and  health 
aspects,  (iii)  for  business  associations  regarding  effectiveness  and  efficiency  –  costs  and 
benefits  aspects,  and  (iv)  for  external  and  internal  coherence.  15  in-depth  interviews  with 
targeted stakeholders (e.g. manufacturers, distributors, NGOs) were held, partly as follow-up 
to  stakeholder  input  provided  via  the  OPC.  A  virtual  workshop  joined  by  around  125 
individuals  was  held  in  March  2020  to  present  the  preliminary  findings  of  the  study  and 
provide stakeholders with another opportunity to give input. 

During  the work on identifying policy options and assessing  their impacts,  the Commission 
asked for feedback within the call for evidence from 14 February to 14 March 2022. The open 
public  consultation  took  place  from  10  March  to  16  June  2022.  Within  this  consultation, 
stakeholders were asked to what extent they agree that it would be beneficial to introduce a 
mandate  in  the  directive  for  the  European  Chemicals  Agency  to  evaluate  requests  for  new, 
renewed  or  for  a  deletion  of  exemptions  from  Annexes  III  and  IV.  There  were  dissenting 
opinions  by  stakeholders  about  the  Agency’s  benefits:  40%  disagreed  and  35%  agreed. 
Another question was addressed to the technical assessment of substances for the restriction 
of hazardous substances in Annex II. Here, most stakeholders (38%) agreed that it would be 
beneficial to introduce a mandate in the Directive for the European Chemicals Agency. 

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The  Member  States’  Expert  Group  for  RoHS  2  (Directive  2011/65/EU)  adaptation  and 
enforcement15  was  consulted  on  26  October  2022  and  on  5  June  2023  about  the  planned 
reattribution  of  the  technical  assessment  of  exemption  requests  and  of  potential  substance 
restrictions  to  the  European  Chemicals  Agency.  The  experts  welcomed  making  provisions 
more streamlined and efficient in different pieces of legislation related to chemicals. The need 
to equip the Agency with sufficient resources and to consider product and waste aspects were 
highlighted.  

A  call  for  evidence  for  the  initiative  on  making  the  best  use  of  EU  agencies  to  streamline 
scientific  assessments  was  published  on  the  Commission’s  Have  your  say  website  on 
15 March  2022.  The  public  and  stakeholders  were  invited  to  provide  feedback  up  until 
12 April 2022. In total, 65 submissions were received. Generally, there was a large support for 
the ‘one-substance, one-assessment’ approach as a whole, as well as for the specific initiative 
on the reattribution of tasks. As regards the call for evidence, 67% of respondents expressed 
their  explicit  support,  23%  did  not  express  explicitly  their  opinion  but  provided  relevant 
advice  on  how  to  develop  the  ‘one  substance,  one  assessment’  approach.  About  10% 
expressed doubts about the usefulness of the initiative or opposition to the initiative. 

Stakeholders  were  also  informed  and consulted on the reattribution of tasks to  EU agencies 
during the Information Session on One Substance, One Assessment with Stakeholders held on 
1 June 2022. 800 participants followed this online event.  

An extensive discussion on reallocating tasks to EU agencies was held with representatives of 
Member  States  and  EU  agencies  at  the  second  meeting  of  the  Expert  Group  on  One 
Substance, One Assessment16 on 2-3 June 2022 and on 30 March 2023. Representatives of 
Member States and EU Agencies participating in the expert group meetings were supportive 
to the initiative as well, providing concrete suggestions on the reattributions. 

Main  input  received  on  reallocating  tasks  to  the  EU  agencies  and  how  this  is  taken  into 
account in the proposal 

Expertise:  

Stakeholders  highlighted  the  need  to  acquire  further  expertise  in  the  field  of  electronic  and 
electrical  equipment  and the end-of-life fate of such equipment  for the ECHA. The Agency 
would be specialised in assessments related to chemicals but evaluating a whole life cycle of 
electrical  equipment  would  require  further  knowledge.  The  Commission  agrees  that  the 
ECHA services and their committees require additional expertise in these fields, in particular 
for the exemption procedure. Nevertheless, the Agency has already experience assessing the 
risk of chemicals in articles and considering the end-of-life stage of articles. The ECHA could 
consult  external  experts  for  specific  electrical  and  electronic  equipment  and  complicated 
cases.  More information on these areas is gathered and knowledge is accumulated over time. 
In  addition,  there  are  services  working  on  these  areas  who  can  support  the  ECHA,  if 
necessary.  This  cooperation  among  services,  here  EU  Agencies,  will  be  strengthen  with  the 
Omnibus Regulation.  

Several  stakeholders  agree  to  the  allocation  of  tasks  to  the  ECHA  and  its  committees  to 
increase  coherence  with  the  ‘one-substance,  one  assessment’  principle.  Other  stakeholders 
questioned  the  allocation  to  the  ECHA  as  it  is  primarily  intended  for  chemicals.  The 
Commission sees strong links between the substance restrictions and the exemption process to 
established  procedures  under  the  REACH  Regulation.  This  is  also  in  line  with  stakeholder 

15 
16 

E02810 - Register of Commission expert groups and other similar entities (europa.eu).  
E03792 - Register of Commission expert groups and other similar entities (europa.eu). 

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7 

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feedback  stressing  the  need  to  better  align  the  authorisation  and  restriction  process  for 
substances  under  REACH  to  the  exemption  process  under  the  RoHS  Directive.  The 
Commission understands that the ECHA is the most appropriate EU Agency to deal with such 
chemical related tasks. 

Resources:  

Stakeholders  insisted  that  the  new  task  to  the  ECHA  must  be  accompanied  by  the  required 
resources.  Reallocating  work  should  not  lead  to  an  agency  or  committee  being  unable  to 
manage the workload and jeopardising the quality of the work. 

The  Omnibus  Regulation  is  accompanied  with  a  detailed  assessment  of  the  EU  agencies’ 
resource  and  capacity  needs  to  ensure  adequate  resources  taking  into  account  synergies  and 
economies of scale.  

Scientific committees:  

It is proposed to involve and the Committee for Risk Assessment and the the Committee for 
Socio-Economic  Analysis,  set  up  pursuant  to  Article  76(1),  point  (c)  and  point  (d),  of 
Regulation  (EC)  No  1907/2006,  for  the  exemption  procedure  as  well  as  for  the  substance 
review. Stakeholders indicated that the agencies might need to be reorganised to deal with the 
increased workload. ECHA’s Committee for Risk Assessment  already has a high  workload. 
The Commission is aware about the increasing workload and sufficient resources are essential 
to  meet  the  expectations.  The  provided  resources  will  also  benefit  the  involved  scientific 
committees.  For  the  proposed  exemption  process,  the  Committee  for  Risk  Assessment  will 
only be involved under certain conditions in order to limit it to the necessary. 

The  structure  of  ECHA  committees  will  be  addressed  as  part  of  the  proposal  for  ECHA’s 
basic act, which is in preparation. All agencies’ scientific committees are independent. 

Tasks to reallocate:  

Stakeholders  suggested  that  the  ECHA  should  be  involved  in  hazard  assessments  of  the 
chemicals and external consultants can remain to provide technical expertise. This approach is 
not supported by the Commission as it could complicate the practical work and risk divergent 
conclusions.  One  central  body  to  manage  and  assess  exemption  requests  or  to  develop  and 
assess restriction dossiers is needed on the working level to avoid inefficiencies. Depending 
on the case, the responsible agency can request external experts to provide further expertise. 

According  to  stakeholders  there  are  benefits  in  applying  well-established  methodologies 
developed  under  REACH  in  the  procedures  under  the  RoHS  Directive.  The  Commission 
agrees  in  general  that  there  is  potential  to  align  methodologies  and  to  use  best-practices  in 
similar procedures to maximise the consistency and efficiency of the processes. That is why, 
the two procedures were aligned with the REACH procedures for granting authorisations and 
restricting substances, wherever possible. For the substance restriction process, this approach 
is  in  line  with  existing  procedures  under  the  REACH  Regulation  and  the  Regulation  (EU) 
2023/154217. 

• 

Collection and use of expertise 

The Commission took into account input provided by the ECHA when it assessed which tasks 
are  worth  (re)allocating  to  the  ECHA,  how  they  should  be  allocated  and  what  effect  it  will 
have on them. 

17 

Regulation (EU) 2023/1542 of the European Parliament and of the Council of 12 July 2023 concerning 
batteries  and  waste  batteries,  amending  Directive  2008/98/EC  and  Regulation  (EU)  2019/1020  and 
repealing Directive 2006/66/EC (OJ L 191, 28.7.2023, p. 1–117). 

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• 

Impact assessment 

Although  (re)allocating  scientific  and  technical  work  to  the  ECHA  will  improve  the 
efficiency, consistency, quality and transparency of EU processes for the benefit of Member 
State authorities, stakeholders and the public, it will have no significant economic, social or 
environment impact on EU scale. The use of synergy effects and the application of established 
methods  can  be  beneficial  for  the  parties  involved,  as  they  increase  the  transparency  and 
clarity of the processes. 

There  is  also  little  discretion  of  the  policy  choice.  In  order  to  achieve  objectives  of  the 
initiative, the consolidation of the technical and scientific work on chemicals at the EU level 
is possible only in the ECHA. Therefore, no formal impact assessment was carried out. 

However, the ‘one substance, one assessment’ package  will have a major impact on the EU 
agencies’ resource and capacity needs. This impact was assessed in detail in cooperation with 
the  agencies  concerned.  The  reallocation  of  tasks  made  as  part  of  the  individual  pieces  of 
legislation were assessed as part of the respective impact assessments. For the reallocation of 
tasks  made  as  part  of  the  Omnibus  Regulation  amending  four  pieces  of  legislation,  the 
assessment  is  presented  in  the  staff  working  document18  to  that  proposal.  That  document 
summarises the impact of all reallocated tasks and assesses their cumulative impact on the EU 
agencies. 

The fitness check of all chemical legislation except REACH also served as an evidence base 
for the proposal. The fitness check concluded on the risks of duplication of efforts, inefficient 
use  of  resources  or  divergent  outcomes  of  the  assessments  stemming  from  the  use  of 
contractors,  Commission  services  and  ad  hoc  expert  groups  in  performing  scientific  and 
technical work next to the similar work performed by the EU Agencies. The fitness check also 
concluded that there are significant opportunities for streamlining the technical and scientific 
work through EU agencies.  

Concerning the specific transfer of tasks under the RoHS  Directive to  the ECHA, a support 
study19  was  concluded  within  the  work  of  identifying  policy  options  and  assessing  their 
impacts. However, a full impact assessment was not seen as appropriate and only preliminary 
results were concluded. As a preliminary impact, it was found that the process can be more 
efficient and stakeholder can benefit of existing assessment and consultation structures (e.g., 
websites, databases). 

Aligning  restriction  mechanisms  of  the  RoHS  Directive  with  the  REACH  mechanism 
described in Articles 69-73 of this Regulation, was also discussed in the same support study. 
Resources have to be allocated to the ECHA to ensure a high-quality assessment. The industry 
might  benefit  from  more  consistent  and  transparent  consultation  steps  in  the  process. 
Administrative  changes  at  Member  State  level  may  be  necessary  to  adopt  to  the  procedural 
changes and communication with ECHA. 

Transferring the whole exemption process and/or the substance review process to the REACH 
Regulation was seen as not appropriate and timely. 

18 

19 

Commission  staff  working  document  accompanying  the  documents  Proposal  for  a  Regulation  of  the 
European  Parliament  and  of  the  Council  amending  Regulations  (EC)  No  178/2002,   (EC)  No 
401/2009,   (EU)  2017/745  and   (EU)  2019/1021  of  the  European  Parliament  and  of  the  Council  as 
regards  the  re-attribution  of  scientific  and  technical  tasks  and  improving  cooperation  among  Union 
agencies  in  the  area  of  chemicals  and  Proposal  for  a  Directive  of  the  European  Parliament  and  the 
Council amending Directive 2011/65/EU of the European Parliament and of the Council as regards the 
re-attribution of scientific and technical tasks to the European Chemicals Agency (SWD (2023) 850) 
Study to support the assessment of impacts associated with the general review of Directive 2011/65/EU 
(RoHS Directive). 

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• 

Regulatory fitness and simplification 

The proposed reallocation of tasks to the ECHA will improve the coherence and efficiency of 
the legal framework on chemicals as a whole. 

Reallocating tasks to EU agencies will create synergies as a result of: 

• 

• 
• 

reusing  existing  expertise  on  hazard,  risk,  exposure  and  socio-economic  assessments, 
development of committee opinions, stakeholder consultation; 
reusing existing hazard and risk data; 
the economies of scale from reusing scientific support services and IT tools. 

The proposed reallocation of tasks will generate added value in terms of improving scientific 
consistency with other legislation and the scientific quality and robustness of assessments. In 
addition,  reallocating  tasks  will  significantly  improve  the  transparency  and  inclusiveness  of 
the processes. It will also guarantee the independence of the processes. 

The proposal has no impact on small and medium-sized companies or micro-enterprises. 

• 

Fundamental rights 

The proposal has no implications for the protection of fundamental rights. 

4. 

BUDGETARY IMPLICATIONS 

The  budgetary  implications  and  the  human  and  administrative  resources  are  described  and 
assessed within the Annex to the Omnibus Regulation amending several regulations under the 
‘one substance, one assessment’ package. 

The scientific and technical  tasks allocated to  ECHA in  this proposal  are existing  tasks that 
are  currently  executed  by  the  European  Commission  by  contracting  external  experts.  The 
allocation  of  tasks  under  this  proposal  will  be  provided  with  sufficient  resources  described 
and  assessed  in  the  staff  working  document20  accompanying  the  proposal  for  a  Regulation 
amending  several  regulations  on  the  reattribution  of  technical  and  scientific  tasks  to  EU 
Agencies.  Aligning  the  procedures  of  these  scientific  and  technical  tasks  with  existing  and 
comparable procedures  under the REACH Regulation  and placing  their  execution under the 
remit of the ECHA will result in an added value of improved quality and scientific robustness 
of  the  assessments,  strengthened  transparency  and  inclusiveness  of  the  procedures,  and 
improved  consistency  with  assessments  conducted  under  other  pieces  of  legislation.  In  the 
long  term,  the  improved  consistency  of  EU  scientific  assessments  will  lead  to  better,  more 
informed, and more efficient policy options for the benefit of the public, the industry, and the 
environment. 

Part of the resources used for the assessments under the RoHS Directive are currently spent 
on procuring the necessary contractual support and amounts approximately 2.8 FTE per year. 

The future resources are calculated for evaluating and managing restriction dossiers, and the 
evaluation  of  exemption  requests,  both  including  issuing  opinions  by  the  relevant  scientific 
committees.  In  addition,  the  ECHA  provides  horizontal  support,  and  develop  and  modify 

20 

Commission  staff  working  document  accompanying  the  documents  Proposal  for  a  Regulation  of  the 
European  Parliament  and  of  the  Council  amending  Regulations  (EC)  No  178/2002,   (EC)  No 
401/2009,   (EU)  2017/745  and   (EU)  2019/1021  of  the  European  Parliament  and  of  the  Council  as 
regards  the  re-attribution  of  scientific  and  technical  tasks  and  improving  cooperation  among  Union 
agencies  in  the  area  of  chemicals  and  Proposal  for  a  Directive  of  the  European  Parliament  and  the 
Council amending Directive 2011/65/EU of the European Parliament and of the Council as regards the 
re-attribution of scientific and technical tasks to the European Chemicals Agency (SWD (2023) 850) 

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existing IT tools.  Scientific and technical support from ECHA for the tasks to be reattributed 
under this proposal will require 3 FTEs (3 TAs) and an operational budget of EUR 66 000 in 
the first year. In the second year, there will be a need of 7 FTEs (4 TAs + 3 CAs) per year and 
operational budget of EUR 33 000 per year. Considering the resources currently used for the 
tasks  to  be  reattributed,  there  will  be  a  total  net  increase  in  the  resources  from  2026  and 
beyond as compared to today of 4.3 FTEs per year and EUR 33 000 per year. 

When issuing an opinion, the scientific committees should appoint one of their members as a 
rapporteur. The person concerned, or his employer, should be remunerated in accordance with 
Article  87  of  the  Regulation  (EC)  No  1907/2006.  The  use  of  experts  for  the  scientific 
committees  to  cover  specific  expertise  by  these  tasks  shall  take  place  in  accordance  with 
Article  87  of  the  Regulation  (EC)  No  1907/2006.  These  measures  should  ensure  that  the 
committees  can  be  provided  with  sufficient  resources.  However,  the  reattribution  of  tasks 
under this proposal will not affect the organisational conditions within the Agency. 

5. 

• 

OTHER ELEMENTS 

Implementation plans and monitoring, evaluation and reporting arrangements 

The  roll-out  of  the  reattribution  of  the  tasks  under  Article  5  and  Article  6  of  Directive 
2011/65/EU to the ECHA requires a sufficient transitional period to allow organisational steps 
and resource allocations. A transitional period of 12 months is seen as sufficient. 

The efficiency in performing the allocated tasks in the EU agencies will be monitored as part 
of  the  regular  evaluation  of  the  agencies’  performance,  once  the  relevant  provisions  are  in 
place in the agencies’ founding regulations.  

• 

Explanatory documents (for directives) 

Due to the limited implications for Member States and the low complexity of this proposal, an 
explanatory document pursuant the Joint Political Declaration of 28 September 201121 is not 
considered necessary. 

• 

Detailed explanation of the specific provisions of the proposal 

Article 1  of  the  proposed  regulation  aims  at  amending  Articles  5  and  6  of  Directive 
2011/65/EU  on  the  restriction  of  the  use  of  certain  hazardous  substances  in  electrical  and 
electronic  equipment22. The amendments  allocate  a role and specific tasks  to  ECHA and its 
scientific  committees  in  the  processes  for  substance  restrictions  and  assessing  exemption 
requests corresponding to the restrictions.  

That amendment should ensure alignment with existing procedures under the Regulation (EC) 
No  1907/200623.  Those  procedures  will  be  adapted  where  relevant  to  the  specific 
characteristics of electrical  and electronic equipment  and the  regulatory system of Directive 
2011/65/EU. 

21 
22 

23 

OJ C 369, 17.12.2011, p. 14. 

Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction 
of the use of certain hazardous substances in electrical and electronic equipment  (OJ L 174, 1.7.2011, 
p. 88). 

Regulation  (EC)  No 1907/2006  of  the  European  Parliament  and  of  the  Council  of  18 December  2006 
concerning  the  Registration,  Evaluation,  Authorisation  and  Restriction  of  Chemicals  (REACH), 
establishing  a  European  Chemicals  Agency,  amending  Directive  1999/45/EC  and  repealing  Council 
Regulation  (EEC)  No 793/93  and  Commission  Regulation  (EC)  No 1488/94  as  well  as  Council 
Directive  76/769/EEC  and  Commission  Directives  91/155/EEC,  93/67/EEC,  93/105/EC  and 
2000/21/EC (OJ L 396, 30.12.2006 , p.1). 

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2023/0454 (COD) 

Proposal for a 

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

amending Directive 2011/65/EU of the European Parliament and of the Council as 
regards the re-attribution of scientific and technical tasks to the European Chemicals 
Agency 

(Text with EEA relevance) 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

Having  regard  to  the  Treaty  on  the  Functioning  of  the  European  Union,  and  in  particular 
Article 114 thereof, 

Having regard to the proposal from the European Commission, 

After transmission of the draft legislative act to the national parliaments, 
Having regard to the opinion of the European Economic and Social Committee1,  

After consulting the Committee of the Regions,  

Acting in accordance with the ordinary legislative procedure, 

Whereas: 

(1) 

The Commission has, in its Communication ‘European Green Deal’2, set an objective 
that  chemical  safety  assessments  should  move  towards  a  process  of  ‘one-substance, 
one-assessment’, calling for more transparent and simpler risk assessment processes in 
order to reduce the burden on all stakeholders, accelerate decision-making, as well as 
to  increase  consistency  and  predictability  of  scientific  decisions  and  opinions.  The 
Commission,  in  its  Communication  on  Chemicals  Strategy  for  Sustainability3 
concludes  that,  in  order  to  achieve  that  objective,  part  of  the  scientific  and  technical 
work on chemicals performed at Union level in support of Union legislation needs to 
be  reattributed  to  the  most  suitable  Union  agencies.  This  would  simplify  the  current 
set-up, improve quality and coherence of safety assessments across Union legislation, 
and ensure more efficient use of existing resources.  

(2) 

The  reattribution  of  certain  scientific  and  technical  tasks  to  the  European  Chemicals 
Agency  is  necessary  in  order  to  align  processes  and  levels  of  scientific  scrutiny  and 
digitalisation  with  current  standards  and  processes  of  the  European  Chemicals 
Agency.  This  is  also  necessary  in  order  to  ensure  a  consistent  standard  of  scientific 

1 
2 

3 

OJ C […], […], p. […]. 
Communication from the Commission to the European Parliament, the European Council, the Council, 
the European Economic and Social Committee and the Committee of the Regions, The European Green 
Deal (COM (2019) 640 final of 11 December 2019). 
Communication  from  the  Commission  to  the  European  Parliament,  the  Council,  the  European 
Economic  and  Social  Committee  and  the  Committee  of  the  Regions,  Chemicals  Strategy  for 
Sustainability Towards a Toxic-Free Environment (COM (2020) 667 final of 14 October 2020). 

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12 

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(3) 

(4) 

(5) 

(6) 

(7) 

(8) 

4 

5 

quality,  transparency,  data  searchability  and  interoperability,  in  line  with  the  ‘one-
substance, one-assessment’ ambition. 
Directive  2011/65/EU  of  the  European  Parliament  and  of  the  Council4  contains  two 
procedures  related  to  the  assessment  of  chemicals:  the  evaluation  of  economic 
operators’  applications  for  granting,  renewing  or  revoking  an  exemption  from  the 
substance  restrictions  pursuant  to  Article  5  of  that  Directive  and  the  review  of 
substances to be added to the list of restricted substances pursuant to Article 6 of that 
Directive. There is a need to increase transparency by setting detailed procedural steps 
for  the  process  to  review  substances  for  a  potential  inclusion  in  the  list  of  restricted 
substances.  

Data  and  information  held  by  the  European  Chemicals  Agency  in  the  context  of 
regulatory  processes  under  Titles  VII  and  VIII  of  Regulation  (EC)  No  1907/2006  of 
the  European  Parliament  and  of  the  Council5  can  be  usefully  deployed  for  the 
assessment  of  potential  substance  restrictions  and  for  assessing  applications  for 
exemption  under  Directive  2011/65/EU.  Established  structures  and  procedures  can 
help to build on the existing knowledge base, maximise synergies, and make the best 
use of available expertise and resources. 

To ensure consistency between the evaluation of economic operators’ applications for 
granting,  renewing  or  revoking  an  exemption  pursuant  to  Article  5  of  the  Directive 
2011/65/EU,  as  well  as  to  make  the  best  use  of  existing  chemicals-related  expertise, 
the technical  evaluation  to  assess the justification of such exemption  requests should 
be  carried  out  by  the  European  Chemicals  Agency  and  its  committees  in  close 
coordination with the Commission.  

To ensure that the restriction process referred to Article 6 in Directive 2011/65/EU is 
consistent with the restriction processes under other legislation related to chemicals, in 
particular  with  the  substance  restriction  process  laid  down  in  Articles  69  to  73  of 
Regulation  (EC)  No  1907/2006,  it  is  necessary  to  amend  Directive  2011/65/EU  to 
formally task the European Chemicals Agency with a role in the restriction process. In 
the light of experience obtained when carrying out substance reviews, it is essential for 
the quality of the related technical assessment, and for enabling synergies, to make use 
of  information  and  tools  being  used  in  the  context  of  assessments  for  chemical 
restrictions under Regulation (EC) No 1907/2006. 

The two procedures described under Article 5 and Article 6 are applicable at the EU 
level.  National  provisions  should  not  deviate  from  these  Articles  set  in  Directive 
2011/65/EU. 

For amending procedural provisions under Directive 2011/65/EU, a transitional period 
of 12 months is necessary to allow for appropriate resource and task allocation for the 
European  Chemicals  Agency.  That  timeframe  is  considered  sufficient  to  allow 

Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction 
of the use of certain hazardous substances in electrical and electronic equipment – OJ L 174 1.7.2011, 
p 88. 
Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 
concerning  the  Registration,  Evaluation,  Authorisation  and  Restriction  of  Chemicals  (REACH), 
establishing  a  European  Chemicals  Agency,  amending  Directive  1999/45/EC  and  repealing  Council 
Regulation  (EEC)  No  793/93  and  Commission  Regulation  (EC)  No  1488/94  as  well  as  Council 
Directive  76/769/EEC  and  Commission  Directives  91/155/EEC,  93/67/EEC,  93/105/EC  and 
2000/21/EC - OJ L 396 30.12.2006, p. 1. 

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13 

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potential applicants or Member States to adjust to the modified procedural steps under 
that Directive.  

(9) 

Directive 2011/65/EU should therefore be amended accordingly, 

HAVE ADOPTED THIS DIRECTIVE: 

Article 1 

Amendments to Directive 2011/65/EU  

Directive 2011/65/EU is amended as follows: 

(1) 

(a) 

Article 5 is amended as follows: 

paragraphs 3 and 4 are replaced by the following:  

‘3. An application for granting, renewing or revoking an exemption shall be made to the 
European Chemicals Agency set up pursuant to Article 75(1) of Regulation (EC) No 
1907/2006 (‘the Agency’) in accordance with Annex V. 

4. The Agency shall: 

(a) 

acknowledge receipt of an application within 15 days of its receipt, stating the 
date of receipt of the application; 

(b)  verify that the application contains all the elements laid out in Annex V; 

(c) 

if necessary, request the applicant to complete the application, and provide an 
appropriate deadline; 

(d)  make  the  application  and  any  supplementary  information  supplied  by  the 

applicant available to Member States; 

(e)  make  a  summary  of  the  application  and  a  non-confidential  version  of  the 
application  as  submitted  by  the  applicant,  as  well  as  the  date  when  the 
application  is  considered  complete,  available  to  the  public  on  the  Agency’s 
website; 

(f) 

invite  interested  parties  to  submit  information  within  3  months  of  its 
publication on the Agency’s website. 

Where  the  applicant  does  not  complete  the  application  with  the  missing  elements 
identified by the Agency in compliance with Annex V within the deadline provided 
in  accordance  with  the  first  subparagraph,  point  (c),  the  Agency  may  reject  such 
application. The Agency shall establish and communicate to the applicant without 
undue delay the date when the application is considered complete. 

Upon  receipt  of  an  application,  the  Agency  shall  notify  the  Commission  of  the 
application and keep it informed of any of the procedural steps under points (b) to 
(f).’; 

(b) 

the following paragraph 4a is inserted after paragraph 4:  

‘4a. The Agency shall, after verifying the completeness of the application, request the 
opinion  of  the  Committee  for  Socio-economic  Analysis,  set  up  pursuant  to  Article 
76(1), point (d) of Regulation (EC) No 1907/2006. It shall request the opinion of the 
Committee  for  Risk  Assessment,  set  up  pursuant  to  Article  76(1),  point  (c),  of 

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14 

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Regulation (EC) No 1907/2006, in the case of an application for a new exemption, or 
where otherwise considered appropriate.  

The Committee for Socio-economic Analysis and, where relevant, the Committee for 
Risk Assessment: 

(a) 

(b) 

shall  draw  up  draft  opinions  within  9  months  of  the  date  the  application  has 
been considered complete by the Agency under paragraph 4, point (b); 

shall  assess  whether  the  criteria  in  Article  5(1),  point  (a),  are  met  and  shall 
provide clear guidance to the Commission  on granting, renewing or revoking 
an exemption; 

(c)  may request the applicant or third parties to submit, within a specified period, 

additional information; 

(d)  upon adopting the draft opinions, shall communicate those draft opinions to the 
applicant  and  shall  allow  the  applicant  the  opportunity  to  comment  within  4 
weeks of the communication of the draft opinions to the applicant; 

(e) 

shall  adopt  their  final  opinions,  taking  into  account  the  comments  from  the 
applicant.  

Each Committee shall take into account any information submitted by third parties in 
accordance with the second subparagraph, point (c). 

The  Agency  shall  send  the  final  opinion(s)  of  the  Committees  to  the  Commission 
within  12  months  from  the  date  an  application  has  been  considered  complete  by  the 
Agency.  

The Agency shall identify which parts of its opinions and of any attachments thereto 
should be made publicly available on its website and shall make those parts publicly 
available on its website. 

For  the  purpose  of  adopting  opinions  pursuant  to  this  paragraph,  Article  87  of 
Regulation (EC) No 1907/2006 shall apply mutatis mutandis.’; 

(c) 

paragraph 8 is replaced by the following: 

‘8.  The  Agency  shall,  in  agreement  with  the  Commission,  provide  a  harmonised 
format  for  the  applications  referred  to  in  paragraph  3  of  this  Article  as  well  as 
comprehensive  guidelines  for  such  applications,  taking  into  account  the  situation  of 
SMEs.  Any  submission  to  the  Agency  shall  be  made  using  the  format  and  the 
submission tools made available by the Agency.’; 

(2) 

in Annex V, the following paragraph is added: 

‘In cases referred to in the first paragraph, point (h), the applicant shall submit a non-
confidential version of the application.’.  

(3) 

(a) 

EN 

Article 6 is amended as follows: 

in paragraph 1, the first subparagraph is replaced by the following: 

‘With a view to achieving the objectives set out in Article 1 and taking account of the 
precautionary principle, a review, based on a thorough assessment, and an amendment 

15 

  EN 

 
 
 
of the list of restricted substances in Annex II shall be considered by the Commission 
periodically on its own initiative or following the submission of a restriction dossier 
prepared by a Member State containing the information referred to in paragraph 2.’; 

(b) 

(c) 

in paragraph 1, the fourth subparagraph is deleted. 

paragraph 2 is replaced by the following: 

 ‘2. The review and amendment of the list of restricted substances in Annex II shall be 
based on restriction dossiers prepared by the Agency at the request of the Commission 
or prepared by a Member State.  

The Agency or a Member State shall take into account any available information and 
any  relevant  risk  assessment  submitted  for  the  purposes  of  other  Union  legislation 
covering the life cycle of the substance used in EEE, in particular the waste phase. To 
this  end,  other  bodies  established  under  Union  law  and  carrying  out  a  similar  task 
shall, on request, provide information to the Agency or Member State concerned. 

The restriction dossier shall comply with the requirements set out in Part II, point 3, of 
Annex  XV  to  Regulation  (EC)  No  1907/2006  and  shall,  in  addition,  contain  the 
following information: 

(a) 

(b) 

information  on  the  use  of  the  substance  or  the  group  of  similar  substances  in 
EEE; 

information on detrimental effects and exposure in particular during waste EEE 
management operations.’ 

(4) 

the following Articles 6a, 6b and 6c are inserted:  

‘Article 6a 

Initiation of procedure for review and amendment of the list of restricted substances 

1. 

2. 

3. 

4. 

Within  12  months  of  receipt  of  the  request  from  the  Commission  referred  to  in 
Article  6(2),  first  subparagraph,  the  Agency  shall  prepare  a  restriction  dossier 
conforming  to  the  requirements  referred  to  in  Article  6(2),  third  subparagraph,  and 
suggest restrictions in order to initiate the restriction process. 

A  Member  State  shall  notify  the  Agency  that  it  proposes  to  prepare  a  restriction 
dossier  which  conforms  to  the  requirements  referred  to  in  Article  6(2),  third 
subparagraph, within 12 months. If that dossier demonstrates that action on a Union-
wide  basis  is  necessary,  beyond  any  measures  already  in  place,  the  Member  State 
shall submit it to the Agency in order to initiate the restriction process. 

The  Agency  shall  publish  without  delay  the  intention  of  the  Commission  or  the 
Member  State  to  initiate  the  process  to  review  and  amend  the  list  of  restricted 
substances in Annex II. 

The Agency shall establish and maintain a list of substances for which a restriction 
dossier  conforming  to  the  requirements  of  Article  6(2)  is  planned  or  underway  by 
either the Agency or a Member State for the purposes of a proposed restriction. 

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5. 

The  Agency  shall  consult  the  Committee  for  Risk  Assessment,  set  up  pursuant  to 
Article  76(1),  point  (c),  of  Regulation  (EC)  No  1907/2006,  and  the  Committee  for 
Socio-economic  Analysis,  set  up  pursuant  to  Article  76(1),  point  (d),  of  that 
Regulation.  The  Committees  shall  verify  whether  the  restriction  dossier  submitted 
conforms to the requirements referred to in Article 6(2), third subparagraph.  

Within  30  days  of  receipt  of  the  restriction  dossier,  the  respective  Committee  shall 
inform  the  Agency  or  the  Member  State  proposing  restrictions  whether  the  dossier 
conforms  to  the  requirements  referred  to  in  Article  6(2),  third  subparagraph.  If  the 
dossier  does  not  conform  to  those  requirements,  the  reasons  shall  be  given  to  the 
Agency or the Member State in writing within 45 days of receipt of that dossier. The 
Agency or the Member State shall bring the dossier into conformity within 60 days 
of the date of  receipt of  the reasons from  the Committees, otherwise the  procedure 
under this Article shall be terminated. 

Where  the  dossier  meets  the  requirements  referred  to  in  Article  6(2),  third 
subparagraph,  the  Agency  shall  make  it  publicly  available  without  delay,  clearly 
indicating  the  date  of  publication.  The  Agency  shall  invite  all  interested  parties, 
including  economic  operators,  recyclers, 
treatment  operators,  environmental 
organisations  and  employee  and  consumer  associations  to  submit,  individually  or 
jointly,  within  4  months  from  the  date  of  the  publication  of  the  dossier,  the 
following: 

comments on dossiers and the suggested restrictions; 

a socio-economic analysis including an analysis of alternatives, or information which 
can  contribute  to  one  of  the  suggested  restrictions,  examining  the  advantages  and 
drawbacks of the proposed restrictions.  

The  analysis  referred  to  in  the  first  subparagraph,  point  (b),  shall  conform  to  the 
requirements in Annex XVI to Regulation (EC) No 1907/2006. 

Article 6b 

Opinion of the Agency’s Committees 

Within  12  months  from  the  date  of  publication  referred  to  in  Article  6a(6),  the 
Committee for Risk Assessment shall adopt an opinion as to whether the restriction 
is appropriate in  reducing the risk to human health or the environment, specifically 
by  reference  to  the  risks  set  out  in    Article  6(1),  third  subparagraph,  based  on  its 
consideration of the relevant parts of the dossier. This opinion shall take account of 
the restriction dossier prepared by the Agency at the request of the Commission or by 
the  Member  State,  and  the  views  of  interested  parties  referred  to  in  Article  6a(6), 
point (a). 

Within  15  months  from  the  date  of  publication  referred  to  in  Article  6a(6),  the 
Committee  for  Socio-economic  Analysis,  shall  adopt  an  opinion  on  the  proposed 
restrictions,  based  on  its  consideration  of  the  relevant  parts  of  the  dossier  and  the 
socio-economic impact. Prior to that, it shall prepare a draft opinion on the suggested 
restrictions  and  on  the  related  socio-economic  impact,  taking  account  any  existing 
analysis or information according to Article 6a(6), point (b). 

6. 

(a) 

(b) 

1. 

2. 

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3. 

4. 

5. 

6. 

1. 

2. 

3. 

The  Agency  shall  publish  the  draft  opinion  of  the  Committee  for  Socio-economic 
Analysis  on  its  website  without  delay  and  invite  interested  parties  to  provide  their 
comments on the draft opinion no later than 60 days from its publication. 

The Committee for Socio-economic Analysis shall without delay adopt  its  opinion, 
taking into account where appropriate further comments received by the deadline set 
in  paragraph  3.  This  opinion  shall  take  into  account  the  comments  of  interested 
parties submitted under Article 6a(6), point (a), and paragraph 3 of this Article. 

Where the opinion of the Committee for Risk Assessment diverges significantly from 
the restrictions proposed, the Agency shall postpone the deadline for the opinion of 
the Committee responsible for Socio-economic Analysis by a maximum of 90 days. 

For the purpose of adopting opinions pursuant to this article, Article 87 of Regulation 
(EC) No 1907/2006 shall apply mutatis mutandis. 

Article 6c 

Submission of an opinion to the Commission 

The  Agency  shall  submit  to  the  Commission,  without  delay,  the  opinions  of  the 
Committees  for  Risk  Assessment  and  Socio-economic  Analysis  on  the  restrictions 
suggested  pursuant  to  Article  6b.  Where  the  opinions  of  the  Committees  for  Risk 
Assessment and Socio-economic Analysis diverge significantly from the restrictions 
suggested  by  the  dossier,  the  Agency  shall  submit  an  explanatory  note  to  the 
Commission providing a detailed explanation of the reasons for such differences. If 
one or both of the Committees do not adopt an opinion by the deadlines set in Article 
6b(1)  and  (2)  the  Agency  shall  inform  the  Commission  accordingly,  stating  the 
reasons. 

The  Agency  shall  publish  the  opinions  of  both  Committees  on  its  website  without 
delay. 

The  Agency  shall,  on  request,  provide  the  Commission  or  Member  State  with  all 
documents and evidence submitted to or considered by it.’; 

The  provisions  under  this  Directive  shall  be  applicable  from  [OJ:  12  months  after  the 
publication of this Directive]. 

Article 2 

This Directive shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union. 

Article 3 

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This Directive is addressed to the Member States. 

Done at Brussels, 

Article 4 

For the European Parliament 
The President 

For the Council 
The President 

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